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FDA Breakthrough Therapy Designation: GSK Receives Approval For Additional Indication For Promacta

August 26, 2014

GlaxoSmithKline (GSK) announces on August 26th that the  FDA approves a supplemental New Drug Application (sNDA), for the once-daily use of Promacta (Eltrombopag) in patients with Severe Aplastic Anemia (SAA), who have had an insufficient response to Immunosuppressive Therapy (IST). Promacta is a new 1st-in-class treatment option for previously treated SAA patients.

Eltrombopag is marketed under the brand name Promacta in the US and Revolade in most ex-US countries. In addition to the approval of Promacta for SAA in the US, eltrombopag is indicated for the treatment of thrombocytopenia in patients.

SAA is a rare disorder where the bone marrow fails to make enough new blood cells. There are currently no therapies approved for this indication. About forty percent (40%) of patients who do not respond to initial IST die within 5 years of diagnosis.

FDA Regulatory Actions

•   Orphan Drug Designation (ODD) in May 2008 & approval in November 2008 for Thrombocytopenia

•   ODD in November 2013 for Aplastic Anemia

•   Breakthrough Therapy Designation (BTD) in February 2014 for cytopenias in patients with SAA who have had insufficient response to IST

•   Priority Review in April 2014

•   Approval for additional indication in August 2014 for patients with SAA who have had insufficient response to IST.

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “Icon Announcer” by Orion 8 [Public domain] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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